Knee Replacement Device Unapproved, but Used in Surgery

The maker of the OtisKnee surgical guides started selling them before seeking clearance from the Food and Drug Administration, which later rejected the application.

Source: NYT Health - February 6, 2015 Category: Consumer Health News Authors: By MARSHALL ALLEN and OLGA PIERCE Tags: ProPublica Malpractice Medical Devices Surgery and Surgeons Stryker Corporation SYK NYSE Knees Implants American Academy of Orthopedic Surgeons Source Type: news